Keynote presentation by Jeffrey Sailstad: Co-organizer of the Crystal City III meeting, co-author of the meeting’s proceeding paper and a co-guest editor of the AAPS Journal themed issue dealing with bioanalytical method validation

The importance of transferring bioananlytical techniques, such as flow cytometry and multiplex bioanalysis, from the research lab to a regulated environment for use in early clinical trial endpoints

14:00:00

Assessing and implementing quality in your bioanalytical studies: Should GLP, GCLP or another system be followed? • What are the GLP guidelines and is GLP suitable to follow? • How do GCLP guidelines differ from GLP, and will these be accepted as a standard? • Using available texts to develop your own system of practice • How to ensure that all laboratories used are up to a suitable standard if they are not accredited Brian A. Roberts, Sr. Life Scientist, Science Applications International Corporation (SAIC), USA